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PSNC: FMD funding to be discussed in 2019-20 contract negotiations

PSNC CEO Simon Dukes: Negotiations for the 2019-20 pharmacy contract have not yet started

The government has agreed to discuss the possibility of remuneration for pharmacies complying with the EU scanning law as part of the sector’s funding for 2019-20, PSNC has said.

The Falsified Medicines Directive (FMD) – created to prevent counterfeit medicines from entering the supply chain – will require every pharmacy in the UK to scan barcodes and check tamper-proof devices from February 9, 2019.

The Medicines and Healthcare products Regulatory Agency (MHRA) has not published specific calculations of the cost of the legislation to community pharmacies, but its impact assessment estimates that “healthcare institutions” face paying up to £4,000 every five years to buy scanners to comply with the directive.

Reena Barai, a contractor and National Pharmacy Association (NPA) board member, said pharmacy owners continue to be concerned about the associated costs of complying with the FMD.

“Every contractor I have met over the last couple of days has said that is the one thing they want to find out about at the Pharmacy Show,” she said at the conference in Birmingham yesterday (October 7).

In response, Mr Dukes said: “I don't know yet, is the answer. I have flagged this significantly with the government.”

“[The government] knows we want to talk about it. They have asked and I've agreed to discuss it in the 2019-20 contract negotiations,” he added.

“Those negotiations are yet to start. I am hopeful that they will do so in the next month, and [the FMD] is on the agenda.”

“No pot of money for FMD”

Speaking in a separate session on the FMD, Claymore Richardson, senior policy manager for pharmacy at the Department of Health and Social Care (DH), told delegates: “There is no big pot of money for implementing FMD.”

The DH has been working with NHS Digital and others on “the options for people working in the community”, Mr Richardson added.

In the same session, Raj Patel, chair of the UK FMD working group for community pharmacy, insisted: “There needs to be a pot for FMD.”

Contract negotiations “need to gather pace” if pharmacies are to afford FMD hardware and software installation by the February 2019 deadline, he added.

Leon Finnerty, NHS Digital FMD programme manager, said that rather than see it as a “burden”, pharmacists should consider the positive impact medicines scanning could have on the sector – including greater control over their stock and drug shortages.

“Take the fact that you've got [to comply with the] FMD as a given,” he told delegates, before suggesting they ask themselves: “How can I turn this into a benefit for me?”

Last month, PSNC confirmed that the first meetings with government officials to negotiate England’s pharmacy funding for 2018-19 have started, but warned that the sector “owes the government a lot of money”.

Richard MacLeavy, Non Pharmacist Branch Manager

Posted on Sun, 21/10/2018 - 22:19

How does scanning packs of medicines help drug shortages?

Its ok for Claymore to say there isn't a big pot of money in DH for FMD but neither is there a big pot of money in contractors pockets. DH need to decide to either fund it or not bother with it, especially as we will only be non compliant for a few weeks before leaving the EU anyway. As contractors though we absolutely should not fork out for this without there being suitable implementation, and operating funding in place.

A B, Community pharmacist

Posted on Sat, 13/10/2018 - 10:25

Seems strange (but unsurprising) that we are having to pay for this before funding is agreed or even discussed. When ETP was first introduced in pharmacy we received a payment for setup costs. I can't see why the same isn't happening here

Susan M Shepherd, Community pharmacist

Posted on Tue, 09/10/2018 - 17:21

FMD compliance is a very significant issue with respect to Brexit. If the UK goes ahead and leaves the EU on 29th March, in the absence of a deal covering this issue, access to the European database is lost, so that any existing stock cannot be decomissioned. Any new stock arriving from the EU will already be decomissioned as the UK is then a 3rd country. So we face having to sign a contract for several years and redesign our dispensaty layout and practices for something we can only operate for 2 months.

The MHRA announced in a consultation document, published on 4 October 2018, which looked at medicines regulation in the event of a no-deal Brexit with no implementation period, that the FMD would be revoked in the UK.

The document says: “In the unlikely event of no deal being agreed with the EU before 29 March 2019, we expect the UK would not have access to the EU central data hub, and therefore stakeholders would be unable to upload, verify and decommission the unique identifier on packs of medicines in the UK.

Mike Hewitson, Superintendent Pharmacist

My big concern is that this is going to be the mother of all unfunded mandates. "You've got to do it, but we're not going to pay for it".

Comments ascribed in this article to NHS Digital give me more cause for concern:

Leon Finnerty, NHS Digital FMD programme manager, said that rather than see it as a “burden”, pharmacists should consider the positive impact medicines scanning could have on the sector – including greater control over their stock and drug shortages.

“Take the fact that you've got [to comply with the] FMD as a given,” he told delegates, before suggesting they ask themselves: “How can I turn this into a benefit for me?”

They are trying to pass this off as a professional obligation, rather than a contractual requirement because they don't want to pay for it. They'll try and use GPhC and MHRA to force compliance using the threat of sanctions.

As it stands the biggest cost is not hardware or software but the inefficiency that FMD is likely to drive into the dispensing process, along with the risk of 'false positives' i.e. drugs which aren't fake, but for some reason the barcode is rejected.

The sector cannot absorb additional costs without a guarantee on future funding. We're having to sign contracts now for potentially 3 years which will start costing us from now. The vague possibility of funding at some point down the line, potentially offset against some over-delivery elsewhere doesn't cut it. It isn't as though we haven't known for 2 years that FMD has to be implemented by February 2019. Even if this is included in the next round of negotiations, it is unlikely that something will be finalised by this time next year, which means some contractors might have been incurring costs for over a year before they see a penny.

Ashley Cohen, Community pharmacist

Posted on Mon, 08/10/2018 - 16:54

Please note "The govenment has agreed to discuss THE POSSIBILITY of remuneration......

Considering we are into month 7 of 18/19 and still no news of our contract i am not sure its worth holding our breath. I am hesitant to invest heavily in our group without the reimbursement model being explaned or on whether post Brexit we need to compy with this EU directive.